Unicycive Therapeutics, Inc. (NASDAQ: UNCY) has announced that the U.S. Food and Drug Administration (USFDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. CKD patients on dialysis with hyperphosphatemia are often saddled with an onerous treatment regimen that includes having to take as many as 12 pills per day. OLC is likely to result in better patient adherence over currently available treatment options as it requires a lower pill burden in terms of the number and size of pills per dose, and the pills are swallowed instead of chewed for added convenience. Unicycive has entered into a long term manufacturing contract with Shilpa Medicare for the supply of the product at commercial scale once approved by the USFDA. With Unicycive's NDA now under review, it is expected to commercialize and launch OLC in the US market in the second half of calendar year 2025.Powered by Capital Market - Live

Shilpa Medicare will hold a meeting of the Board of Directors of the Company on 13 November 2024Powered by Capital Market - Live

The domestic equity indices traded with major losses in mid-afternoon trade. The Nifty hovered below the 24,200 level. Bank shares extended losses for the two trading session. Trading could be volatile due to monthly F&O series expiry today. At 14:30 IST, the barometer index, the S&P BSE Sensex, tumbled 596.06 points or 0.75% to 79,339.11. The Nifty 50 index declined 155.05 points or 0.64% to 24,185.45. In the broader market, the S&P BSE Mid-Cap index fell 0.64% and the S&P BSE Small-Cap index shed 0.75%. The market breadth was positive. On the BSE, 2,457 shares rose and 1,380 shares fell. A total of 121 shares were unchanged. Both, BSE and NSE will conduct the Muhurat trading session on Friday, 1 November, from 6:00 pm to 7:00 pm. While markets remain closed during the day, this evening session allows investors to make token investments, following a long-standing custom of trading during Diwali. Buzzing Index: The Nifty Bank index fell 0.84% to 51,370.25. The index declined 0.34% in the two trading sessions. DFC First Bank (down 3.11%), Punjab National Bank (down 2.69%), Bank of Baroda (down 1.1%), ICICI Bank (down 1.02%), Canara Bank (down 0.97%), Axis Bank (down 0.96%), State Bank of India (down 0.89%), Federal Bank (down 0.83%), IndusInd Bank (down 0.61%) and HDFC Bank (down 0.54%) declined. Numbers to Track: The yield on India's 10-year benchmark federal paper advanced 1.85% to 6.953 as compared with previous close 6.945. In the foreign exchange market, the rupee edged lower against the dollar. The partially convertible rupee was hovering at 84.0950, compared with its close of 84.0850 during the previous trading session. MCX Gold futures for 5 December 2024 settlement shed 0.36% to Rs 79,445. The US Dollar index (DXY), which tracks the greenback's value against a basket of currencies, was down 0.03% to 103.96. The United States 10-year bond yield declined 0.89% to 4.237. In the commodities market, Brent crude for November 2024 settlement added 12 cents or 0.17% to $72.67 a barrel. Stocks in spotlight: Shilpa Medicare fell 0.95%. The company announced that the US FDA had issued four observations to its Bengaluru-based facility post the conclusion of an inspection. The company informed the company's Unit- VI, Dabaspet, Bengaluru, India, was inspected by USFDA on 24, 25 and 28, 29, 30 October 2024. The inspection was the onsite GMP inspection of this site. Automotive Axles slipped 2.20% after the company's standalone net profit declined 20.20% to Rs 35.97 crore on 15.35% decrease in revenue from operations to Rs 494.68 crore in Q2 September 2024 over Q2 September 2023. Powered by Capital Market - Live

In a regulatory filing made during market hours today, the company informed the company's Unit- VI, Dabaspet, Bengaluru, India, was inspected by USFDA on 24, 25 and 28, 29, 30 October 2024. The inspection was the onsite GMP inspection of this site. The inspection concluded with the issuance of Form 483 with four observations. All observations are procedural in nature. 'The company shall respond to the observations within the time frame,' Shilpa Medicare said. This unit of Shilpa Medicare is engaged in the manufacturing, testing and release of oral mouth dissolving films and transdermal systems. The site has already been approved by MHRA-UK and TGA Australia and has US FDA approval for supplying nutraceutical oral film products into US and other markets. Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance. The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% YoY to Rs 292.51 crore in the quarter ended 30 June 2024. Powered by Capital Market - Live

Desmopressin is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis. Desmopressin helps to reduce frequent urination and excessive thirst. This is used to treat central diabetes insipidus and bedwetting. Keshav Bhutada, Executive Director- Shilpa Pharma Lifesciences said, 'We at Shilpa have always been investing in challenging chemical synthesis. With unwavering commitment and belief in our technical capabilities, we have invested in developing a versatile peptide portfolio over past few years and Desmopressin is the first peptide molecule to receive CEP from the European Regulators. This CEP showcases our proficiency in quality-oriented development as well as commercial manufacturing capabilities that meet the expectations of global quality standards paving way for more such products to follow.' The scrip slipped 4.92% to end at Rs 793.60 on Thursday, 3 October 2024.Powered by Capital Market - Live

Shilpa Medicare's 100% subsidiary, Shilpa Pharma Lifesciences received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Desmopressin. Desmopressin is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis. Desmopressin helps to reduce frequent urination and excessive thirst. This is used to treat central diabetes insipidus and bedwetting. Powered by Capital Market - Live

Shilpa Medicare announced the appointment of Dr. Sridevi Khambhampaty, as Chief Executive Officer (CEO) of Shilpa Biologicals, a wholly owned subsidiary of Shilpa Medicare. The appointment is effective 19 September 2024 Powered by Capital Market - Live

Sridevi Khambhampaty y is a recognized leader in the Biologics industry with over two decades of expertise in developing products for the Indian, US and EU markets. She has a PhD in Biophysics from NCBS-TIFR Bangalore, and also has a postdoctoral fellowship from Stanford University, California. Khambhampaty has an overall techno commercial experience of over 22 years in various organizations, notably in Lymphoma specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance. The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% year on year to Rs 292.51 crore in the quarter ended 30 June 2024. Shares of Shilpa Medicare dropped 4.89% to Rs 860.35 on the BSE. Powered by Capital Market - Live

The said drug is used for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. In an exchange filing, the company said that Unicycive Therapeutics, Inc. has announced submission of NDA to USFDA for Oxylanthanum Carbonate. Unicycive has partnered with SML to provide end-to-end contract development and manufacturing organisations (CDMO) services right from development of APIs specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance. The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% year on year to Rs 292.51 crore in the quarter ended 30 June 2024. The counter hit an all time high of Rs 823.95 in today's intraday session. Powered by Capital Market - Live

Unicycive Therapeutics, Inc. (NASDAQ: UNCY) announced the submission of NDA to U.S. FDA for Oxylanthanum Carbonate for treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC). Unicycive has partnered with Shilpa Medicare to provide end-to-end CDMO services right from development of APIs & formulation to supply of finished dosage form. Unicycive has entered into long term manufacturing and supply agreement with Shilpa Medicare for all its commercial requirements in the market starting from Q1 - FY 2025-26. Commenting on the event, Vishnukant Bhutada - Managing Director, Shilpa Medicare mentioned, 'Submission of this NDA demonstrates delivery of high quality developmental services by Shilpa to it CDMO customers and strengthens its credentials as a one-stop reliable partner for all the CDMO requirements of global pharma companies. We are very pleased to have partnered with a like-minded team of Unicycive to deliver path breaking treatments for patients suffering from chronic diseases.Powered by Capital Market - Live